RBW are partnered with a global biotech organisation that are seeking an experienced and driven Associate Director in Clinical Pharmacology to support a rapidly growing portfolio of therapeutics targeting central nervous system disorders. This role offers a unique opportunity to contribute to cutting-edge clinical development in a dynamic and collaborative environment.
Responsibilities:
* Serve as the clinical pharmacology lead providing scientific and strategic guidance to project teams
* Provide guidance for dosing regimen and informing best strategy for modelling techniques
* Perform PK and PK/PD analyses to support clinical trial design and execution
* Contribute to regulatory submissions, including briefing documents, INDs, CTAs, and NDAs
* Overseeing development of junior clinical pharmacology scientists
* Support scientific publications through the preparation of abstracts and manuscript
Requirements:
* PhD in clinical pharmacology, pharmacokinetics or a relevant field
* Extensive experience in the pharmaceutical or biotech industry, with a strong background in clinical pharmacology and PK/PD modeling
* Previous hands on Population PK/PD modelling and simulation experience is desirable
* Strong knowledge of clinical pharmacology guidelines for regulatory submissions
* Proficient user of NONMEM, Phoenix WinNonlin, R etc